UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000027764
Receipt number	R000031818
Scientific Title	Comparison of effect on skin microbial flora, skin moisturisation and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels
Date of disclosure of the study information	2017/06/15
Last modified on	2018/06/16 15:43:37

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Basic information

Public title

Comparison of effect on skin microbial flora, skin moisturisation and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels

Acronym

The effect on skin and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels

Scientific Title

Comparison of effect on skin microbial flora, skin moisturisation and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels

Scientific Title:Acronym

The effect on skin and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To investigate the effect on skin and relaxation by the partial bed bath using cotton towels and the partial bed bath using disposable wet towels

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Number of skin bacteria, the water content in epidermal stratum corneum and relaxation

Key secondary outcomes

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

The partial bed bath using cotton towels
Check of six times for a day (before practice, just after, 10 minutes later, 20 minutes later, 30 minutes later and 60 minutes later practice)

Interventions/Control_2

The partial bed bath using disposable wet towels
Check of six times for a day (before practice, just after, 10 minutes later, 20 minutes later, 30 minutes later and 60 minutes later practice)

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Eligibility

Age-lower limit

65 years-old <=

Age-upper limit

90 years-old >=

Gender

Female

Key inclusion criteria

Healthy females

Key exclusion criteria

-Subjects who have been suffered from a critical disease
-Subjects with allergy
-Subjects who are in poor physical condition
-Subjects who have an abnormality of measurement skin site
-Subjects undergoing trauma in the measurement site
-Subjects who are influenced by the adhesive
-Subjects deemed inappropriate to participate in this study by the principle investigator

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Chiharu Matsumoto

Organization

Kumamoto University

Division name

Faculty of Life Sciences

Zip code

Address

4-24-1, Kuhonji Chuo-ku , Kumamoto, Kumamoto, 862-0976, JAPAN

TEL

+81-096-373-5517

Email

matsu-c@kumamoto-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Chiharu Matsumoto

Organization

Kumamoto University

Division name

Faculty of Life Sciences

Zip code

Address

4-24-1, Kuhonji Chuo-ku , Kumamoto, Kumamoto, 862-0976, JAPAN

TEL

+81-096-373-5517

Homepage URL

Email

matsu-c@kumamoto-u.ac.jp

Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name

Funding Source

Organization

NITI-ON

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

NITI-ON

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2017 Year 06 Month 15 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Both disposable bath and towel bath significantly decreased resident skin bacteria. Disposable bath also significantly reduced Staphylococcus aureus and effectively maintained the hydration level of the stratum corneum. Furthermore, disposable bath was as effective as towel bath at contributing to participants' relaxation levels.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 05 Month 01 Day

Date of IRB

Anticipated trial start date

2017 Year 10 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2018 Year 03 Month 31 Day

Other

Other related information

Management information

Registered date

2017 Year 06 Month 15 Day

Last modified on

2018 Year 06 Month 16 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031818

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name